MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT

Model Number	H7493941812270
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment and shaft break occurred.The patient presented with coronary artery disease.A 2.75 x 12mm synergy xd drug eluting stent was advanced for treatment.However, the device was unable to advance over the wire and became stuck.The wire was in the body but the stent never advanced far enough to enter the body.When the physician tried to pull the stent from the wire, the stent delivery system broke off.Both devices were removed from the body and the procedure was completed with new wire and new stent.There were no patient complications reported.
Event or Problem Description
It was reported that device entrapment and shaft break occurred.The patient presented with coronary artery disease.A 2.75 x 12mm synergy xd drug eluting stent was advanced for treatment.However, the device was unable to advance over the wire and became stuck.The wire was in the body but the stent never advanced far enough to enter the body.When the physician tried to pull the stent from the wire, the stent delivery system broke off.Both devices were removed from the body and the procedure was completed with new wire and new stent.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.75 x 12mm stent delivery system was returned for analysis.The device was returned with extensive stent damage.The stent struts were bunched from the proximal section to the mid section.As a result of the damage , the stent outer diameter (od) was not taken.A review of the manufacturing stent profile data was performed and the stent od at the time of manufacture was within max crimped stent profile measurement.The balloon cones were reviewed, and the section of the stent damaged was also damaged on the balloon.The balloon was bunched at the proximal section.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube identified a break on the hypotube shaft located at 121cm distal to the distal end of strain relief as well as multiple kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen identified shaft extrusion damage.A 0.014 inch guidewire could be advanced without issues through distal tip but could not advance past inner shaft damage with bunching from the end of the proximal balloon cone to approximately 15 mm proximal of the shaft.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16410261
• Report Number: 2124215-2023-07665
• Device Sequence Number: 3504699
• Product Code: NIQ
• UDI-Device Identifier: 08714729980872
• UDI-Public: 08714729980872
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2023
• Device Model Number: H7493941812270
• Device Lot Number: 0028065976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown